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New treatment option for Melanoma
Official title A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
ClinicalTrials.gov ID: NCT01638676
What this study is testing
What is Vemurafenib?
Vemurafenib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for melanoma.
Also referred to as Vemurafenib branded as Zelboraf.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The main purpose of this study is to evaluate the safety of Vemurafenib in combination with Metformin in melanoma patients. The phase II part of the study will also evaluate the clinical activity of the combined regiment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patients ≥ 18 years of age;
- Patients with histological confirmed BRAFV600E melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
- Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 2;
- Life expectancy ≥ 3 months;
- At least 1 site of radiographically measurable disease by RECIST 1.1
You likely can't join if
- Prior treatment with Vemurafenib;
- Known hypersensitivity to Metformin or any of its components;
- Previous progression of melanoma while on Metformin;
- Received radiotherapy for non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all...
- Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
- Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study
See the full eligibility criteria
- Male or female patients ≥ 18 years of age;
- Patients with histological confirmed BRAFV600E melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
- Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 2;
- Life expectancy ≥ 3 months;
- At least 1 site of radiographically measurable disease by RECIST 1.1
- Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:
- Absolute neutrophil count (ANC) ≥ 1.0 x 109/L;
- Platelet count ≥ 50 x 109/L;
- Hemoglobin ≥ 8 g/dL;
- Serum creatinine ≤ 2 x upper limit of normal (ULN)
- Total serum bilirubin ≤ 3 x ULN;
- Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤ 3x ULN, and ≤ 4 x ULN if liver metastases are present.
- Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician;
- Pre-menopausal females and females \< 2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time...
- Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
- Prior treatment with Vemurafenib;
- Known hypersensitivity to Metformin or any of its components;
- Previous progression of melanoma while on Metformin;
- Received radiotherapy for non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to Grade ≤ 1, except for alopecia;
- Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
- Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study
The study team makes the final eligibility decision.
Where it's taking place
- Louisville, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Louisville, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.